A Phase 1 Study Of Cmc-544 Administered In Combination With Rituximab In Subjects With B-cell Non-hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Number of Participants With Dose-limiting Toxicities (DLT)
研究概览
简要总结
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in combination with Rituximab in patients with B-Cell Non-Hodgkin's lymphoma (NHL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
- •Prior therapy must have contained at least one dose of Rituximab therapy. Patients can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0/
- •Patients must not have received previous radioimmunotherapy.
- •Patients tolerant to Rituximab.
- •Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 28 days before first dose of test article.
排除标准
- •Candidate for potentially curative therapies
- •Subjects must not have received previous radioimmunotherapy.
- •Subjects with autologous hematopoietic stem cell transplant within the last 6 months
研究组 & 干预措施
Inotuzumab Ozogamicin + Rituximab
干预措施: Inotuzumab Ozogamicin (CMC-544) (Drug)
Inotuzumab Ozogamicin + Rituximab
干预措施: Rituximab (Rituxan) (Drug)
结局指标
主要结局
Number of Participants With Dose-limiting Toxicities (DLT)
时间窗: Up to 28 days
A DLT was defined as the following drug-related adverse event which occurred during the first 28 days: 1) Any National Cancer Institute (NCI) Grade 3 or 4 nonhematologic toxicity (except Grade 3 nausea or vomiting without optimal treatment), 2) Febrile neutropenia, 3) Grade 4 absolute neutrophil count lasting \>=7 days, 4) Grade 4 thrombocytopenia lasting \>=3 days, 5) Grade 3 or 4 thrombocytopenia associated with a bleeding episode requiring platelet transfusion, 6)Delayed recovery (to grade \<=1 or baseline, except alopecia) from a drug-related toxicity that delayed the next dose \>2 weeks
次要结局
- Number of Participants With Objective Response: Evaluable Population(Up to 8 cycles (1 cycle = 28 days))
- Number of Participants With Objective Response: Intent-to-treat (ITT) Population(Up to 8 cycles (1 cycle = 28 days))
- Progression-Free Survival (PFS)(Up to 591 days)